Lean Product Development directly addresses these risks. It focuses on value-adding work, reduces waste, and helps teams make better decisions earlier, when change is cheaper and options are still open. When development work is misaligned with business goals or customer needs, the consequences usually appear later as delays, rework, or in-market problems. Lean principles help create more predictable, outcome-focused development by improving information flow, enabling fast learning, and supporting decision-making under uncertainty. The goal is not just to work efficiently, but to reduce the risk of failure by choosing better paths sooner.

As part of my International Industrial Management studies in Germany, I wrote my master’s thesis on Lean Management in Indirect Areas, meaning Lean applied beyond the factory floor. I also worked as a Lean Navigator at Bosch, applying Lean principles within engineering and central quality teams. That experience reinforced an important point. Lean Product Development is not simply Lean Manufacturing applied earlier in the process.

Manufacturing focuses on repeatable, physical outputs. Once a product is in production, the aim is consistency, efficiency, and minimal variation. Product development is different. It is a knowledge-based process filled with uncertainty, learning, and iteration. The biggest sources of waste are rarely physical. They tend to be unnecessary complexity, late decisions, poor communication, or rework caused by problems discovered too late.

Understanding this distinction is essential if Lean is going to reduce risk rather than create frustration.

Although Lean originated in manufacturing, its principles apply anywhere value, services, or information flow to meet customer demand. While there is no single definition of Lean, five core principles are widely recognised:

• Identify what the customer values
• Analyse which activities truly add value
• Create continuous flow
• Establish pull, where work is triggered by downstream demand
• Eliminate waste
  

The purpose of Lean is not cost cutting for its own sake. Waste reduction is a means to improving quality, responsiveness, and reliability, not the end goal. A genuinely Lean organisation is usually characterised by two things:

• Responsibility is placed as close as possible to value creation
• Problems are traced back to root causes through structured problem-solving
  

When Lean principles are embedded across product development, they improve efficiency and reduce risk by creating clarity, consistency, and faster learning. In practice, I see the greatest impact when teams start by focusing on a small set of guiding principles:

1. Question assumptions, especially early ones
2. Enable decision-making where the action and information sit
3. Use root cause analysis rather than quick fixes
4. Capture knowledge so learning is not lost between projects
5. Identify risks early, before they become expensive
6. Understand customer requirements, both internal and external
7. Build transparency into the development process
   

Transparency deserves special attention. Visibility into progress, risks, decisions, and assumptions allows organisations to respond earlier and more effectively. This does not mean more reporting or micromanagement. It means shared, simple systems that make work visible and encourage honest conversations. Tools like decision registers, design logs, or risk dashboards can help. So can regular check-ins that focus on learning rather than performance.

When everyone, from engineers to leadership, can see how development is really tracking, small issues are addressed before they become major problems. Trust improves, decisions get better, and learning accelerates.

If you want to get started with Lean Product Development, keep it simple. Pick one project. Make the work visible. Ask where decisions are being delayed and why. Look for rework and late surprises and trace them back to their source. Small changes applied consistently can significantly reduce risk over time.

You do not need to transform everything at once. Lean is built through practice, reflection, and steady improvement. Each better decision made earlier strengthens your development process and your confidence in what you are putting into the market.

Many countries and regions around the world are introducing regulations related to data protection. For example, in the EU, the GDPR (General Data Protection Regulation) applies to all businesses that collect data from EU residents. In 2023 alone, breaches of the GDPR resulted in over €1 billion in fines.

Under GDPR, your business is responsible for:

• Notifying authorities within 72 hours of a personal data breach
• Providing full transparency to users about how their data is used
• Deleting data when no longer needed, or if a user revokes consent
• Obtaining clear, freely given consent, especially from users under 16
• Documenting risk assessments and ensuring data is processed lawfully
  

Failure to comply can cost you up to 2% of your global annual turnover.

On the 1 August 2025, the new EU cybersecurity standards (EN 18031 series) became mandatory under the Radio Equipment Directive (RED). These regulations apply to any connected product that can transmit data via the internet. This includes mobile phones, smartwatches, tablets, children’s toys, safety equipment, and baby monitors. Non-compliance could mean:

• Blocked access to EU markets
• Delays in product certification
• Costly redesigns and reputational damage
• Legal exposure if user data is compromised
  

The EN 18031 series of standards introduces security requirements for:

• Internet-connected products
• Products processing sensitive personal data (e.g. children’s devices, toys, wearables)
• Devices used for monetary transactions (e.g. virtual wallets)
  

Their goals are threefold:

• Prevent harm to communication networks
• Protect personal data and user privacy
• Reduce fraud risk, particularly for devices that handle payments
  

To comply, developers must test for network security, data integrity, and resilience to unauthorised access.
As a business leader, you don’t need to know the technical details of encryption or communication protocols, but you do need to know what questions to ask your team, your suppliers, and your technology partners. Start with these:

• Are we building products that comply with EN 18031 and GDPR and other regulations relevant to our markets of sale?
• Have we documented a data security risk assessment?
• How are we managing data consent and withdrawal?
• What happens if our product is hacked?
• Do we have a breach response plan?
• Who in our business is accountable for data protection?
  

As we step into the new year, now is the perfect time to take stock of how your products handle personal data. Thinking proactively about data protection is not just about avoiding fines. It is about building trust with your customers, strengthening your brand, and setting your business up for smoother product launches. Even small actions, like reviewing your consent processes, checking your breach response plan, or confirming your data risk assessments are up to date, can make a big difference. Make 2026 the year you use data security to strengthen customer trust and confidence.

As a product development business or manufacturer, you’re not just designing and making products. You’re learning how to make them safer, more reliable, and better over time. Businesses that do this well treat product development as a continuous learning process, using past experience to drive improvement. That discipline is what separates industry leaders from the rest and helps them stay competitive over the long term.

Creating internal resources, such as product development guidelines, tailored to your products and industry, will:

• Protect and retain high-value, hard-to-recreate knowledge
• Streamline the development process
• Serve to standardise proven design solutions
• Act as a training and onboarding resource
• Contribute to your business’s intangible assets
• Improve consistency across product lines
  

Once a product is on the market, it can be relatively easy for others to copy what they see. What is far harder to replicate is the quality and reliability you have achieved through months or years of refinement, and the way your team approaches product development. Competitors still face a learning curve, which limits their ability to perform at the same level. Your product development guidelines and similar internal documents are trade secrets. They capture how you consistently design great products, not just what those products look like or how they function.
Documenting your trade secrets is only half the equation. You also need to protect them. Many businesses focus on patents but do not always consider how to safeguard their trade secrets or even recognise what they are. Anything that gives your products their quality and consistency and that a competitor would struggle to replicate can be considered a trade secret.

To protect these valuable assets, consider the following practices:

• Implement access control and user permissions: Limit access to internal guidelines and sensitive information based on roles and responsibilities. This prevents unauthorised access or accidental exposure.
• Use secure, encrypted platforms: Transmit and store data securely using platforms that meet industry-standard security certifications such as ISO/IEC 27001. This protects against external threats and unauthorised parties.
• Regularly review and update security protocols: Keep access controls, encryption methods, and backup procedures up-to-date. Regular reviews help mitigate risks as your business grows and new vulnerabilities emerge.
• Ensure employee awareness: Train your team on best practices for handling, sharing, and storing proprietary knowledge. Promote a culture of trust and responsibility around sensitive product information.
• Use legal protections and non-disclosure agreements: When working with external partners, consultants, or contractors, put NDAs and other legal safeguards in place before sharing critical information to reduce the risk of unauthorised disclosure.

Keep in mind that the most common way sensitive information is exposed is through email. Overzealous sales staff, eager to impress potential distributors or retailers, may share technical documentation. Another common risk arises when retailers or distributors request information as part of due diligence or to address a product concern. Many businesses respond by oversharing, sending everything from test reports to internal quality documents. This can unnecessarily expose proprietary or sensitive information.

The key is to retain your hard-won knowledge within your business and protect it carefully. Make sure your teams share only what is strictly necessary and always understand why the information is being requested. The less you expose externally, the lower the risk of misinterpretation, mishandling, or misuse. Once a trade secret or valuable insight leaves your control, it cannot be undone. By capturing knowledge internally and safeguarding it, you ensure your business maintains its competitive edge, product quality, and consistency for the long term.

• Type A Standards – Fundamental Safety Principles: These outline general principles for risk assessment and risk reduction. They apply across a wide range of products and technologies. Example: ISO 12100.
• Type B Standards – Generic Safety Aspects: These address specific safety aspects or safeguards that are applicable across many product types.
  • Type B1: Standards for general safety aspects (e.g. safety distances, surface temperature limits).
  • Type B2: Standards for safety devices (e.g. guards, emergency stops).
• Type C Standards – Product-Specific Standards: These apply to particular product categories or machines and contain detailed requirements tailored to those products. Where a Type C standard exists, it generally takes precedence over Type A or B for the same risks.
  

Using the right combination of type A, B, and C standards makes your product design more robust, defensible, and aligned with industry best practice.

If you are developing an innovative product for which no type C standard exists, you can still apply type A and B standards to demonstrate safety and manage risk. In these cases, thorough risk assessments and well-documented design decisions are critical. Standards become one of several tools for demonstrating due diligence, not the sole indicator of product safety.

Product standards also offer valuable technical knowledge that can enhance your products. International standards such as ISO, IEC, ASTM, CEN, and AS/NZS are developed through collaboration among industry experts, academics, and consumer organisations. This gives them credibility and ensures they reflect current best practices and technical understanding. As a result, they are a powerful resource in product development. Fundamentally, product standards should raise the bar, ensuring that products meet minimum safety and performance expectations, that protect users, the environment, and others affected by their use.

Standards are not just about checking compliance boxes, they help your business anticipate known risks and embed preventive measures into your design and manufacturing processes. Most standard requirements are grounded in past incidents or known failure modes. Type B and C standards often include test methods and even specifications for test equipment. These tests can be integrated into your product verification plans.
When working with suppliers or outsourced manufacturers, referencing relevant standards in contracts and technical specifications helps ensure product consistency and safety. It also reduces ambiguity and strengthens your position if disputes or failures occur.

Like regulations, standards are regularly updated. Ensure your teams are subscribing to update alerts or notifications from relevant bodies. This allows your business to incorporate updates into future product revisions and avoid falling behind evolving expectations.

Product standards are more than technical documents, they’re strategic tools that support quality, safety, and trust. Used well, they help you anticipate problems, reduce risk, and build products that meet both regulatory expectations and customer needs. Whether you're referencing them for compliance, design assurance, or supplier alignment, standards offer a defensible foundation for decision-making in a complex and evolving global market.

Beyond legality, the activities associated with compliance demonstrate that your business has taken appropriate steps to ensure your product is safe (does not pose harm to humans, animals, the environment, or property) and that it protects personal privacy (such as with connected products). Understanding, complying, and staying up to date with regulatory requirements is an important part of any risk management strategy, both to prevent disruption to sales and as a step towards harm prevention.

Typical product regulatory requirements cover aspects such as:

• The physical product design
• The materials and substances it is made from
• Its packaging, including everything written on it and any other point-of-sale information (online or in-store)
• The product’s labelling
• The product’s user instructions
• Any data collected by or related to the product, including how that data is processed

Regulations generally fall into two categories: prescriptive and risk-based. Understanding which approach applies to your product can help you interpret and implement compliance requirements effectively.
Prescriptive regulations spell out in detail what you must do, down to precise measurements, materials, and testing methods. For example, a regulation might specify the exact format of a warning label or set out defined flammability limits.

Risk-based regulations set performance goals rather than specific instructions. They ask you to identify risks and demonstrate that you have adequately mitigated them. For example, the EU’s General Product Safety Regulation requires that products be safe under normal or reasonably foreseeable use but allows flexibility in how businesses achieve and prove that.

Risk-based frameworks require more judgment, and often more documentation to prove that your risk assessments and mitigations are sound. Prescriptive frameworks are generally more straightforward to follow but may limit your design flexibility.

Regulations are often long and detailed because they serve multiple audiences: enforcement authorities, manufacturers, importers, retailers, and sometimes even consumers. They typically include technical requirements, enforcement procedures, and legal definitions, as well as administrative provisions. They may also indicate future proposed activities such as research or further refinement of regulatory requirements.

A useful feature for you to pay attention to is the background or preamble section, which often explains the purpose and intent of the regulation. This context can help your business understand not just what the rules are, but why they exist, offering valuable insight into the risks or market issues that prompted the regulation in the first place.

Taking the time to understand the relevant regulations, not just their content, but their intent and history, provides valuable insight into target markets. By studying regulations closely, it is possible to gain a clearer picture of consumer behaviour, safety concerns, and shifting societal expectations in each market. For example, strict rules around child safety in certain regions reflect both historical incidents and heightened public sensitivity. Likewise, evolving data privacy laws show how consumer trust and digital security have become core market concerns.

As a product business, you also need to focus on the sections of the regulation that outline the responsibilities of manufacturers and importers. These sections will detail what you need to do to comply, such as product testing, documentation, labelling, safety requirements, and obligations to monitor products once they are on the market. It’s also worth checking whether the regulation contains any clauses about penalties or consequences for non-compliance.
If your business also acts as a distributor or retailer, make sure to review those sections too, as responsibilities can overlap, particularly around traceability, record-keeping, and corrective actions (like recalls).

When reading a regulation for the first time, it can be helpful to:

• Start with the scope and definitions: This clarifies whether the regulation applies to your product and how key terms are defined.
• Look at the specific obligations for your business role: Focus on what is required before placing a product on the market and what ongoing obligations exist.
• Note references to standards: Identify any product safety standards that are linked to or referenced within the regulation and determine whether they are mandatory, or voluntary.
• Check transitional arrangements or deadlines: Some regulations have phased implementation periods that may affect your timeline.
• Pay attention to annexes or appendices: These sections often contain the technical detail, test methods or limits, or specific requirements that are critical for compliance.

By reading regulations with these points in mind, you will get a clearer picture of your compliance obligations and avoid missing key requirements that could lead to delays or penalties.
During product development, it’s crucial to incorporate relevant regulation and standards requirements early. Doing so fosters better design, stronger safety outcomes, and more secure market positioning. It prevents redesign work at a later date and ultimately ensures a better product.

In short, regulations are not just legal hurdles, they are signals. They help an organisation:

• Anticipate emerging risks
• Understand where products fit within the market landscape
• Design with both compliance and consumer expectations in mind

Finally, it is also important to remember that compliance isn’t a one-and-done task. Regulations evolve in response to new risks, technological advances, political changes, and societal concerns. For example, shifts in data privacy laws, environmental priorities, or product safety concerns can trigger updates that directly affect your obligations.
To stay compliant, it’s essential to monitor for relevant changes. Many regulatory bodies provide mailing lists or update bulletins. If your business operates across multiple regions, a compliance calendar or tracking system can help you stay on top of updates and ensure your product documentation reflects the latest requirements.

In practice, this means:

• Regularly reviewing regulations and standards relevant to your products
• Updating design files, safety documentation, and marketing materials as needed
• Communicating changes with your manufacturing partners and distributors to ensure compliance across the supply chain

Ultimately, robust regulatory compliance is both a legal requirement and a strategic tool. By embedding compliance early and maintaining vigilance throughout your product’s lifecycle, you not only safeguard your business against fines, recalls, and reputational damage, you also build trust with regulators, partners, and consumers. Done well, compliance becomes a mark of credibility that sets your product apart in competitive markets.

A risk assessment as a standalone risk mitigation exercise is never enough. It should support your other risk mitigation activities that are achieved through:

• Compliance with regulations and standards (particularly the intent of those)
• Tailored verification testing
• Integration of learnings from your business’s own experiences and that of others in your industry
• Your teams sound engineering design practices
  

By carrying out a formal risk assessment, your business is taking a pause in its development activities, to specifically think about potential failures and risks. We all know, when you are in the thick of it, it is easy to overlook things that might otherwise seem obvious.

Many product regulations require some form of risk assessment or risk analysis. For example:

• Machinery Regulation (EU): Requires a risk assessment to be carried out. The key harmonised standard is ISO 12100, which outlines principles and methodologies for identifying hazards and evaluating risks across the machinery lifecycle.
• Low Voltage Directive (EU): Mandates an adequate analysis and assessment of risks, though it does not provide a specific harmonised standard for risk assessment.
• General Product Safety Regulation (EU): Requires internal risk analysis for consumer products but does not prescribe a specific harmonised risk assessment standard.
• Toy Safety Directive (EU): Requires a safety assessment but leaves the method and format of the assessment to the discretion of the manufacturer.
• Pressure Equipment Directive (EU): Requires hazard and risk analysis to determine the appropriate conformity assessment route.
• Medical Device Regulation (EU): Requires a comprehensive risk management system throughout the product lifecycle. The harmonised standard ISO 14971 provides the framework for identifying, evaluating, and managing risks in medical devices.

Additionally, more specific standards can supplement these frameworks, such as ISO 13849-1, which focuses on Safety of Machinery, Safety-related Parts of Control Systems. This standard delves deeper into functional safety, particularly control systems that detect and respond to failures (e.g., emergency stop functions and interlocks). It defines performance levels, which are informed by ISO 12100 assessments, ensuring that if a failure occurs, the control system detects the issue and mitigates harm.

Failure Modes Effects Analysis (FMEA) is another widely used risk assessment method, particularly in the automotive industry, although it’s also useful for non-automotive products. The AIAG & VDA FMEA Handbook defines three key types of FMEA:

• System FMEA: Conducted on the entire system or product.
• Design FMEA: Conducted on the product design often at component level.
• Process FMEA: Conducted on the manufacturing or assembly process.

FMEA-Monitoring and System Response is also covered in the handbook and focuses on how a system monitors itself and responds to failures during operation. This is particularly relevant for safety-critical systems, such as Advanced Driver-Assistance Systems. It relates to Design FMEA in a similar way that ISO 13849-1:2015 relates to ISO 12100.
The principles of these FMEA types can be adapted to create a model that best addresses the specific risks you need to capture. For example, incorporating guidelines from ISO 12100 to break down lifecycle risks, including shipping, unpacking, commissioning, usage, maintenance, and disposal, can add significant value.

Some keys to ensuring an effective risk assessment process include:

• Starting with objectives and tailoring the risk assessment accordingly: Unless your teams first clarify what it is they want to assess, they risk overlooking the very issues that matter most.
• Keeping the assessment up to date: The initial assessment identifies and prioritises risks, followed by actions to mitigate them. Then the risks must be reassessed to confirm they’ve been addressed and to check that no new risks have been introduced. When product changes occur later, such as post-market improvements, the risk assessment must be revisited for the same reason.
• Supporting assessments with data: For critical risks, it’s worth actively working on how to obtain that data, whether through testing or simulation methods.
• Ensuring foreseeable misuse is included in the assessment: Foreseeable misuse involves uses that are unintended but can be reasonably anticipated based on the product’s design, instructions, or context of use. These are scenarios where misuse is predictable, allowing the manufacturer to take steps to mitigate the associated risks.
• Eliminating serious risks identified entirely: The goal for serious risks such as death, permanent injury, or injuries requiring medical attention, must be to eliminate the risk entirely, not just reduce its likelihood to make it appear acceptable.

A risk assessment is not just paperwork. When used well, it brings rigour to intuition, challenges assumptions, and helps prevent the kinds of failures that are always obvious in hindsight. Treat it as a living tool, review it often, and use it to strengthen your design and decision making at every stage.

Ensuring your business is correctly categorising its products makes it much easier for the relevant legal, safety, and performance requirements to be determined. It also helps in identifying where multiple sets of requirements might apply if your product fits into more than one category. This is an essential part of effective product risk management and ensures your business can plan ahead to meet all necessary obligations.

As products become more complex over time, they tend to enter additional categories. For example, a company might start with a simple mechanical product (machinery or consumer product) and later decide to motorise it (electrical and electronic equipment). They might then add a battery (battery product) and incorporate Bluetooth functionality (communications equipment). You can see how, as the product evolves, it spans more and more regulatory categories. When these additions are overlooked from a compliance perspective, the risk of non-compliance, and associated penalties or safety issues, increases significantly.

For a business to accurately determine where its product fits, it needs to be clear on who the customer is, what the product’s intended use is (and in what environment), and any specific claims made about the product. If you claim a product is, for example, “non-toxic”, “hypoallergenic “, “fire-resistant”, “clinically-proven” or “alleviates pain”, you can inadvertently be categorising your product in a way you haven’t intended. As an example, if you were marketing a walking stick, how you position and communicate that product will influence its category. If you promote it as an aid for a disability or for injury rehabilitation, it becomes a medical device or a therapeutic good. However, if it’s simply marketed as a general walking stick for fitness or leisure, with no therapeutic claims, it would be classified as a consumer product.

Regulatory categories do vary by market or the terminology may be slightly different, but these are some common categories that your products may fit into:

• Animal Feed: Substances or mixtures intended for consumption by animals to provide nutrition, support growth, or maintain health.
• Aviation/Aerospace Products: Aircraft, drones (often separately regulated), and all certified parts and systems used in flight.
• Battery Powered Products: Products containing batteries.
• Biocides: Any chemical substance or microorganism intended to destroy, deter, render harmless, or control harmful organisms by chemical or biological means.
• Chemicals / Hazardous Substances: Any substance or mixture (raw material or final product) with intrinsic hazardous properties (e.g., corrosives, carcinogens, flammables, toxins).
• Child Care Articles: Consumer products designed or intended primarily for children 12 years of age or younger.
• Communications Equipment: Electrical or electronic products that intentionally emit and/or receive radio waves for communication or location purposes (e.g., Wi-Fi routers, Bluetooth devices, mobile phones).
• Construction Products: Products manufactured for incorporation in a permanent way in construction works (e.g., cement, structural steel, insulation materials, plumbing materials).
• Consumer Products: Non-food, non-medicine products intended for use by the general public (e.g., clothing, household goods, DIY tools).
• Cosmetic Products: Substances or preparations intended for contact with external parts of the human body (e.g., skin, hair, nails) for the purpose of cleaning, perfuming, changing appearance, or correcting body odours.
• Electrical and Electronic Equipment: Products that require electric current or electromagnetic fields to operate, including household appliances, IT equipment, and lighting.
• Equipment for Explosive Atmospheres: Equipment and protective systems intended for use in potentially explosive atmospheres, such as environments with flammable gases or dust (commonly referred to as ATEX equipment).
• Fertilising Products: Substances or mixtures intended to supply nutrients to plants or fungi, improve crop yield, or enhance soil properties.
• Food: Substances intended for human consumption, including beverages and chewing gum, but excluding medicinal products.
• Food Contact Materials (FCM): Materials that are intended to come into contact with food (e.g., plastic containers, cutlery, coffee mugs, processing machinery surfaces).
• Gas Appliances: Appliances burning gaseous fuels for purposes such as heating, hot water, cooking, refrigeration, or lighting.
• Lifts: Equipment permanently serving buildings or construction sites, designed to move people or goods between different levels.
• Machinery: Products with parts that move via a drive system other than human or animal power. Typically designed to perform a specific function or task (e.g., industrial machines, agricultural equipment).
• Marine Equipment: Products intended for use on ships, subject to international conventions (e.g., SOLAS) (e.g., life-saving appliances, navigation equipment, fire protection systems).
• Measuring Instruments: Devices intended to determine a quantity, size, or other measurable property, often subject to accuracy requirements (e.g., weighing scales, gas meters).
• Medical Devices or Therapeutic Goods: Products designed to interact with the body for medical or physiological purposes, such as diagnosis, prevention, or managing body functions, but that do not rely mainly on drugs or chemicals to work (e.g., syringes, diagnostic kits, prosthetics).
• Medicinal Product: Substances or combinations of substances intended to treat or prevent disease, or to restore, correct, or modify physiological functions by exerting a pharmacological, immunological, or metabolic action.
• Motor Vehicles and Components: Cars, trucks, motorcycles, trailers, and their essential safety-critical parts (e.g., brakes, lights, emissions systems, safety glass).
• Packaging: Products made of any materials used to contain, protect, handle, deliver, and present goods, from raw materials to processed goods, across the supply chain (e.g., bottles, boxes, pallets).
• Personal Protective Equipment (PPE): Equipment designed to be worn or held by a person to protect against health and safety risks (e.g., helmets, gloves, respirators).
• Pressure Equipment: Vessels, piping, safety accessories, and other components that operate under pressure, typically above 0.5 bar (e.g., boilers, pressure cookers).
• Pyrotechnics: Products designed to produce heat, light, sound, gas, smoke, or a combination of these effects through exothermic chemical reactions (e.g., fireworks, flares).
• Toys: Products designed or intended for use in play by children under 14 years of age.
  

That is in no way an exhaustive list, but you may already notice that your products fit into more than one category.
Another common pitfall, using our walking stick example, is when a product is initially classified as a non-medical device, but later, the marketing team promotes it for use in hospitals or for injury recovery. Even though the product itself hasn’t changed, its intended use and market positioning have, which can introduce significant compliance risks for the business. Ensure that your marketing teams understand that changing users, use environments or making specific claims can have regulatory implications.

The right categorisation ensures that your business can identify the applicable legal, safety, and performance requirements early in the process. Once you are clear on your product categories, you are in a much better place to accurately identify relevant product regulations and standards. Another activity that helps with this is your product risk assessment which we will look at in the next newsletter.

If your part drawings are clear, you can send the parts back as non-conforming. But if your drawings fail to communicate the critical aspects of your product, you may have no recourse.

Clear, unambiguous part and product drawings are an important tool for reducing product risk. They ensure everyone involved, from internal teams to external suppliers, has the same understanding of what is required.

Good drawings or specifications are also essential for diagnosing problems, both in production and once a product is in the market. They make it easier for suppliers to provide feedback, raise concerns, or suggest improvements early, before costly tooling or production errors occur. As your business grows, they help maintain consistency by reducing reliance on verbal instructions or institutional knowledge.

Your product drawings also form a key part of the contractual agreement between you and your supplier. They define whether the supplier has met their obligations if something goes wrong.

To reduce risk and protect both parties, every drawing should include a few essential elements:

1. Unique drawing or part number and revision: Ensures tooling and production are based on the correct and current design, avoiding errors from outdated references.
2. Exact specification of material and key properties: Prevents substitutions that compromise performance or compliance.
3. Part finish and coating thickness: Surface finish affects function, aesthetics, and corrosion resistance. Coating thickness impacts fit and durability.
4. Part colour: Helps avoid rework or scrap caused by incorrect colour batches and informs tooling or surface preparation decisions.
5. Product size dimensions as reference: Confirms the part has not been inadvertently scaled during file handling or translation.
6. All critical dimensions and tolerances: These affect performance, safety, and durability.
7. Interface dimensions, tolerances, and fit types (for example, interference, sliding): Ensure correct fit with mating parts.
8. Dimensions tied to regulatory compliance: Prevents non-compliance, liability, or recalls.
9. Dimensions to be checked on first-off or start-of-batch parts: Catches early issues before full production.
10. Reference to the 3D model file and revision: Links the drawing to the exact geometry used for tooling.
11. Identification of primary or critical faces: Ensures cosmetic or functional surfaces are protected and properly handled throughout manufacture.

Your drawings are also valuable intellectual assets and should be treated as such. In litigation or regulatory investigations, you may be required to submit them as part of your documentation.

The quality of your drawings says more than just what a part looks like. It signals:

• the level of design maturity within your business
• the thoroughness of your engineering processes
• your team’s approach to safety, compliance, and traceability
  

Poorly prepared or inconsistent drawings suggest product development may have been rushed, poorly controlled, or not fully understood.

In contrast, clear, complete, and professionally presented drawings reflect a business that takes its responsibilities seriously. They demonstrate a culture of rigour and accountability, qualities that carry weight with legal counsel, investigators, and insurers.

In high-stakes situations, your drawings are not just tools for manufacturing, they are evidence of how well you manage product risk.

The plan defines pass/fail criteria for each requirement and will likely include some of the following:

• Size and weight verification: Confirms that the product meets dimensional and weight specifications, including checks on the packaged size.
• Functionality testing: Verifies that the product performs as required, confirming that all functions, features, and capabilities meet the intended use and user needs.
• Configuration and accessory matrix verification: Verifies that the product works correctly with all compatible configurations and accessories, ensuring proper fit, functionality, and performance when used with optional components.
• Actuation force testing: Ensures that all actuators (such as buttons, levers, and pedals) require an appropriate force for operation, verifying both functionality and ergonomic usability.
• Environmental testing: Simulates real-life environmental conditions by exposing the product to factors such as UV radiation, salt spray, dust ingress, humidity, and temperature fluctuations. Accelerated ageing parameters are used to mimic the long-term environmental exposure the product will experience over its lifespan.
• Static loading testing: Assesses the product’s ability to withstand static loads or pressures, ensuring it can support expected stresses without failure. This includes freight loading tests, which simulate the pressures of being stacked during transportation, such as at the bottom of a shipping container.
• Packaging and drop testing: Evaluates the durability of the packaging and the product itself by simulating drops, impacts, and handling during shipping and distribution. This ensures the product can withstand typical logistics hazards and arrive safely and undamaged to the end user. It also ensures that dropping the product does not create hazards for the user.
• Shaker table testing: Simulates transportation conditions to ensure that fasteners, assemblies, and other components do not loosen or malfunction due to vibration during shipping and handling.
• Safety mechanism and critical component testing: Focuses on the durability and reliability of critical components and safety features, verifying they remain functional throughout the product’s lifecycle, even after extended or intensive use.
• Strength, durability, endurance, and wear testing: Simulates real-world use by subjecting the product to continuous use or repeated cycles until failure (where appropriate). This evaluates longevity, strength, and durability across all configurations and accessory combinations.
• Life expectancy testing: Estimates the product’s overall lifespan by assessing performance and durability over extended use. This includes evaluating wear, failure modes, and verifying that the product meets the life expectancy targets.
• Regulatory compliance testing: Ensures the product meets all relevant material and product regulations, safety standards, and certifications at the local, regional, and global levels.

The design of the product verification plan is critical. Careful thought must be given not only to the design of each individual test but also to the sequence in which tests are performed. One sample product may be subject to multiple consecutive tests to ensure the worst-case scenario.

A well-designed product verification plan is more than just a series of tests; it is a comprehensive, dynamic system that safeguards the integrity of your product and your business. It ensures that every stage of development, from prototype to first-off production units, is rigorously evaluated against clearly defined criteria. By incorporating both controlled lab tests and real-world simulation testing, you can comprehensively assess how your product will perform under ideal conditions and in unpredictable, real-world scenarios.
The value of a product verification plan also extends far beyond the immediate product cycle. It becomes a strategic asset that builds on the lessons of previous iterations, fortifying your business’s expertise and protecting against costly failures.

Additionally, it provides invaluable insights that improve not only your product but your entire development process. By continuously refining your verification plans based on real-world feedback, your organisation improves its product development and maintains a competitive edge.

Ensuring you have a good process around creating, updating and using product verification plans is an essential aspect of effective product risk management. These activities will pay dividends in preventing failures in market, warranty costs and potential product recalls.

A Lifecycle Assessment (LCA) captures this broader view. It evaluates environmental impacts across the entire lifecycle of a product, from material extraction to manufacturing, use, and end-of-life. LCAs cover more than carbon emissions, including human toxicity and impacts on water, air, and soil. These insights are essential for prioritising product improvements and avoiding situations where one activity reduces carbon emissions but creates greater harm elsewhere.

Energy use is often concentrated in upstream stages such as material extraction and manufacturing, and downstream stages such as waste and recycling. These areas may remain invisible if you only track operational emissions. Lifecycle assessment helps reveal these blind spots and ensures product decisions are made with the full picture in mind.
A simple way to begin is to select one product and:

1. Gather product information: Use the bill of materials (BOM) or disassemble a product for reference.
2. Map the lifecycle: Identify key upstream, assembly, and downstream activities, including material extraction, manufacturing, transport, use, and end-of-life.
3. Identify environmental loads: For each stage, note major inputs and outputs such as energy use, emissions, and waste.
4. Link to impacts: Connect these with common categories like climate change, resource depletion, human toxicity, or water and soil pollution.

Talking with suppliers can also be valuable. Many may already be tracking some form of environmental data. There are also simple online LCA tools available to build understanding within your organisation. Starting this work now will prepare you for evolving regulatory expectations.

Regulation is increasingly shaping product and packaging requirements. Recent EU measures, such as the Ecodesign for Sustainable Products Regulation (ESPR) (EU 2024/1781, 2024) and the Packaging and Packaging Waste Regulation (PPWR) (EU 2025/40, 2024), set a clear direction:

• Products must be designed for longer lifespans, easier repair, and higher recyclability.
• Packaging must be minimised, reusable, recyclable, or compostable.

Similar rules apply to batteries, with requirements for durability, replaceability, substance restrictions, and carbon footprint tracking. These frameworks are likely to influence global markets, so treating them as a minimum benchmark rather than a compliance checkbox is wise. Designing ahead of regulation reduces risk and can uncover cost savings and competitive advantage.

Sustainable design goes further than making a product recyclable or reducing energy use. It requires considering materials, processes, and impacts across the full lifecycle. Many improvements can be made immediately through smarter design, including:

1. Reduce material usage: Conserve resources and lower costs through lightweighting or substitution.
2. Minimise part count: Simplify designs to cut waste, improve repairability, and make recycling easier.
3. Improve durability: Design products to last longer, reducing replacements and waste.
4. Design for repair: Make common failure points accessible and replaceable to extend product life.
5. Standardise components: Use shared parts (e.g., batteries, adapters) across products to reduce total material demand.
6. Reduce packaging and single-use consumables: Minimise size and layers, and favour reusable, recyclable, or compostable options.
7. Design for end-of-life recovery: Choose separable materials, avoid harmful coatings, and label for reuse or recycling.
8. Lower energy use, including digital services: Improve operational efficiency and reduce unnecessary data transmission, which drives energy use in servers and cloud storage.

Sustainability will continue to evolve. By asking better questions, assessing lifecycle impacts, and making incremental improvements, you can reduce risks, meet emerging regulations, and create products that are not only market-ready but also aligned with a liveable future.
 
Sources:
EU 2024/1781 (2024) Regulation (EU) 2024/1781 establishing a framework for setting ecodesign requirements for sustainable products, Official Journal of the European Union. Available at: https://eur-lex.europa.eu/eli/reg/2024/1781/oj (Accessed: 17 July 2025).
EU 2025/40 (2024) Regulation (EU) 2025/40 on packaging and packaging waste. Available at: https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng (Accessed: 17 July 2025).
McKinsey & Company (2024) What are Scope 1, 2, and 3 emissions? Available at: https://www.mckinsey.com/featured-insights/mckinsey-explainers/what-are-scope-1-2-and-3-emissions (Accessed: 17 July 2025).